1. Field of the Invention
The invention relates to a sterile connector assembly. More particularly, it relates to a sterile connector having enhanced protection of blood or other fluids against environmental contamination.
2. Description of the Prior Art
Various sterile docketing devices, or sterile connectors, have been proposed in the art. Such devices have not generally been satisfactory for commercial applications, however, because of various problems associated with the design and handling characteristics of such connectors. In one approach, for example, heat supplied by an external source must be applied to the area being mated by the two parts of the connector. In another approach, a thin film of folded material is employed to cover and isolate each of the sterilized connector parts. After the parts have been locked together, the films may be pulled, as by means of thin U-shaped tabs thereon, so as to remove the films in such a way that only the sterile surfaces of the connector parts are in contact, elastomeric seals behind the films being released and joined from both sides to maintain the sterile environment. Film thickness is a problem in this approach, as a very thin film may not withstand the force of the pulling action while a thicker film is subject to folding difficulties.
In the latter approach, the folding line is always at least twice the thickness of the film, resulting in a potential for contamination as the film is removed. The film and seal arrangement is also incapable of withstanding any measurable pressure, such as those of autoclaving and centrifugal pressures. In addition to the adherence of the elastomeric seals to the connector body parts, the films are sealed to said elastomeric material, thus introducing adhesion problems and potential contamination to the compressible interface.
A genuine need exists, therefore, for a practical sterile connector capable of achieving enhanced sterility protection while providing simplified operating characteristics and adaptability to the conditions under which such connectors would be employed in the processing of blood and other fluids. In medical and particularly in blood transfusion fields, connections between bags and tubes to establish fluid flow paths must be made without exposing the interior of the coupling connectors to contamination by air or through infection by microorganisms. Because of existing limitations associated with the presently available means of connection, the post thaw period in blood freezing and washing operations, and in the field of blood component separation, is presently limited to a 24-hour outdating period. This limitation constitutes a severe restriction that is a major concern to blood processing agencies confronted with the proper utilization of available blood supplies, particularly when the need for such supplies becomes acute as during emergency situations. The development of a sterile connector has been recognized as a key to the alieviating of such problems as by the highly desirable extension of said post thaw period beyond the present 24-hour period.
It is an object of the invention, therefore, to provide a practical sterile connector.
It is another object of the invention to provide a sterile connector having enhanced sterility protection.
It is another object of the invention to provide a sterile connector having convenient operating characteristics for practical connector applications.
It is a further object of the invention to provide sterile connectors having simplified operating capability coupled with enhanced assurance against contamination of blood or other fluids passing through said connectors.